EP3178519A1 - Systèmes et dispositifs de canule réglables - Google Patents

Systèmes et dispositifs de canule réglables Download PDF

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Publication number
EP3178519A1
EP3178519A1 EP17150761.9A EP17150761A EP3178519A1 EP 3178519 A1 EP3178519 A1 EP 3178519A1 EP 17150761 A EP17150761 A EP 17150761A EP 3178519 A1 EP3178519 A1 EP 3178519A1
Authority
EP
European Patent Office
Prior art keywords
cannula
expandable member
housing
expandable
tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP17150761.9A
Other languages
German (de)
English (en)
Inventor
Ralph Kerns
Prashant Bhadri
Matthew Mccormick
Anderson Gustavo Teixeira Pinto
Mark Humayun
Luis Arana
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Doheny Eye Institute of USC
Original Assignee
Doheny Eye Institute of USC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Doheny Eye Institute of USC filed Critical Doheny Eye Institute of USC
Publication of EP3178519A1 publication Critical patent/EP3178519A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3431—Cannulas being collapsible, e.g. made of thin flexible material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • Embodiments of the invention relate to cannulas and trocars and, in particular, to devices, systems, and methods for adjusting opening sizes of cannulas.
  • Cannulas typically are tubes inserted into a body part for allowing insertion of fluids, materials, or instruments through the cannula or to allow the drainage or removal of fluids.
  • a cannula The smaller in cross-section that a cannula is, the less trauma is caused to the tissue surrounding the cannula.
  • Recent developments in ophthalmology provide a good example of the benefits of small diameter cannulas. It has become increasingly common for vitreoretinal surgery to use cannulas sized small enough to pass instruments of 23 gauge (ga.) or less through the cannula. This then allows the incision from the cannula site to be small enough to self-seal without having to use sutures.
  • This self-sealing of the incision in-turn allows the cannula to be inserted transconjunctivally, saving time and eliminating the need to incise and retract the conjunctiva before incising the sclera, as required using 20 ga. or larger instruments. While the use of smaller sized cannulas has been beneficial, the necessity of using smaller sized instruments has reduced the efficiency of some aspects of surgery compared to the older standard of using 20 ga. instruments. For example, the use of a vitreous cutter with a 23 ga. or smaller outer diameter takes more time to remove vitreous compared to a 20 ga. outer diameter cutter. Also, the insertion of viscoelastic material through a 23 ga.
  • an adjustable cannula system for performing eye surgery comprises a bottom housing for placement on an eye, the bottom housing comprising first and second lumens.
  • the system further comprises an expandable member configured to increase and decrease from one diameter to another, the expandable member to be received in the first and second lumens of the bottom housing.
  • the expandable member includes a distal end for insertion into the eye.
  • At least two coupling elements are located at a proximal end of the expandable member.
  • the bottom housing is configured to engage one of the coupling elements, while the top housing is configured to engage the other of the two coupling elements.
  • the diameter of the expandable member can be controlled by rotating the top housing relative to the bottom housing.
  • a cannula system in some embodiments, includes an expandable member formed as a coil that increase and decreases from one diameter to another.
  • the cannula system further includes a bottom housing for coupling to and receiving the expandable member including a lumen defining a maximum diameter and a top housing for coupling to the expandable member and to the bottom housing. Coupling of the top and bottom housings forms a detent mechanism providing and maintaining a plurality of expandable member diameters when the top housing is rotated relative to the bottom housing.
  • a cannula system comprising an expandable tube having a first tab and a second tab.
  • a bottom housing is coupled to the expandable tube via the first tab and a top housing is coupled to the expandable tube via the second tab, wherein rotation of the top housing relative to the bottom housing results in expansion or contraction of the expandable tube.
  • an adjustable cannula comprising an elongate body having a distal end and a proximal end, wherein the proximal end has a lumen larger than a distal end lumen.
  • a plurality of flanges are formed in the elongate body by a plurality of slits spanning a majority of a length of the elongate body. Material is formed between the flanges at the distal end for maintaining an initial minimum diameter of the distal end lumen.
  • an adjustable cannula comprising an elongate body having a distal end and a proximal end, the proximal end having a lumen larger than a distal end lumen.
  • a plurality of flanges is formed in the elongate body by a plurality of slits spanning a majority of a length of the elongate body.
  • an adjustable cannula comprises an elongate body having a distal end and a proximal end, the proximal end having a lumen larger than a distal end lumen.
  • a plurality of flanges is formed in the elongate body by a plurality of slits spanning a majority of a length of the elongate body. Material is formed between the flanges and substantially fills the slits.
  • the material defines an initial minimum diameter of the cannula, wherein the material has an initial small cross-sectional width upon insertion into tissue and expands to a subsequent larger cross-sectional width at some time after insertion into the tissue so that a working channel of the cannula is enlarged by the material expanding and causing the flanges to separate.
  • a cannula system anchored in the pars plana of an eyeball comprising an expandable member that increases and decreases from one gauge to another by electroactive action.
  • an adjustable cannula system comprising an elongate body having a proximal portion and a distal portion, wherein an inner diameter of the proximal portion is greater than an inner diameter of the distal portion.
  • a plurality of slits extend from the proximal portion to the distal portion, wherein the slits are configured to accommodate expansion and contraction of the elongate body.
  • cannula as used is a broad term, and unless otherwise indicated, may mean, without limitation, a tube, coil, hose, or the like for insertion into a body part.
  • the term cannula may also encompass devices with or without trocars or devices where the cannula itself also functions as a trocar to create in incision.
  • Cannulas can be used to deliver or remove fluids, gases, drugs, materials, oils, tissues, instruments, samples, devices, or the like to and from the body.
  • the diameter of cannulas can be increased, decreased, expanded, or collapsed. Such adjustments of the cannulas can be performed mechanically, thermodynamically, or by using electrical current.
  • Cannulas can be constructed of any suitable material. For example, metals such as nitinol, stainless steel, or the like, or the cannulas can be formed of various plastics or polymers such as polyamide, parylene, or polyurethane.
  • the adjustable cannula provides an adjustable port opening enabling surgical procedures in various parts of the body.
  • the adjustable cannula can be configured to have a small initial diameter, thereby allowing the adjustable cannula to be inserted into small incisions in the body. During the surgery, the surgeon can expand the cross-section or diameter of the adjustable cannula to increase the working channel.
  • the adjustable cannula can be used in tissue having an elastic, flexible, or resilient characteristic, thus advantageously allowing the diameter of the adjustable cannula to expand and permitting the tissue to return to the approximate size of the initial small incision and self-seal without the need for sutures. By removing the need for sutures, patient discomfort is reduced and/or the risk of infection is decreased. In the case of orthopedic surgeries or other surgeries, a reduced initial surgical opening can minimize scaring and/or decrease the amount of healing time as well as the risk of infection.
  • the adjustable cannula can be used in the technology fields of orthopedics, ophthalmology, neurosurgery as well as other technology fields.
  • the adjustable cannula can be universal, such that is can be applied to many different technologies.
  • the adjustable cannula can have diameter range of 3 mm - 9 mm in the orthopedics field.
  • the adjustable cannula can have diameter range of 0.4 - 1 mm in the ophthalmic field.
  • the adjustable cannula can have diameter range of 1 mm - 4 mm in the neurosurgery and orthopedic fields.
  • FIG. 1 shows an adjustable cannula 100, in accordance with the present invention, and in use in an eye 101.
  • the adjustable cannula 100 can be placed transconjunctivally through the sclera 108, as shown, to provide a port opening for placing, inserting and removing, injecting and aspirating, surgical instruments, fluids, gases, or the like.
  • Adjustable cannula 100 may include a top housing or hub 102, a bottom housing or hub 104, and an expandable member or tube 106.
  • FIG. 1 shows an adjustable cannula 100, in accordance with the present invention, and in use in an eye 101.
  • the adjustable cannula 100 can be placed transconjunctivally through the sclera 108, as shown, to provide a port opening for placing, inserting and removing, injecting and aspirating, surgical instruments, fluids, gases, or the like.
  • Adjustable cannula 100 may include a top housing or hub 102, a bottom housing or hub
  • the expandable member is in the form of a cylindrical tube (or other conduit with a lumen there through) having a diameter; however, one skilled in the art will appreciate that the expandable member 106 can assume other forms, including non-tubular (e.g., square, oval, asymmetrical, conical) forms.
  • sutures may be required to close and seal the incision after completing surgery. Incisions 20 ga. or larger generally require sutures to close and seal the incision.
  • the use of sutures may cause complications, for example, suture irritation, inflammation, post-operative astigmatism, scleral pigment changes, or the like.
  • some surgeons prefer self-sealing sutureless techniques, for example, making small incisions and inserting a 23, 24, 25 ga., or smaller cannula or port into the eye.
  • incisions of 23, 24, 25 ga., or smaller allow the incision to self-seal or substantially self-seal after the operation and therefore does not require the use of sutures.
  • cannulas or ports having a size of 23, 24, 25 ga., or smaller can affect the efficiency and/or efficacy of the surgery. For example, it generally takes more effort and time to inject gas and fluid (for example, silicone oil) through a 23, 24, or 25 ga. port compared to a 20 ga. port.
  • gas and fluid for example, silicone oil
  • surgeons are limited in the types and sizes of instruments that can be used during surgery using 23 ga. or smaller instruments compared to the older traditional 20 ga. instruments. For example, surgeons cannot insert as large of a light instrument through a 23 ga. or smaller port compared to a 20 ga. port, thereby possibly impeding the surgeon's ability to illuminate and visualize the posterior chamber of the eye.
  • an adjustable cannula 100 is provided.
  • the adjustable cannula 100 includes an expandable member 106 in the form of a tube that is in part cylindrical with a diameter, while in other embodiments, the expandable member 106 can assume other forms without a diameter, while still being expandable and contractible.
  • the adjustable cannula 100 may have a small initial diameter for use as a 23, 24, 25 ga., or smaller port, and, advantageously, the surgeon can expand the diameter of the adjustable cannula 100 to increase the working channel to potentially accommodate a 20 ga. or larger instrument.
  • the adjustable cannula system allows surgeons to make smaller incisions in the body without sacrificing the greater efficiency of a larger diameter size of the working channel.
  • the resilient, elastic nature of the tissue allows the tissue to return to approximately its initial small self-sealing size after removal of the adjustable cannula 100, despite the cannula 100 having expanded the initial incision to accommodate a larger working channel.
  • tissue can return to approximately near or at their original position prior to displacement or stretching by the cannula.
  • a surgeon may initially insert an expandable tube 106 sized to accommodate a 23, 25, 27, 28 ga. or smaller port in the eye.
  • the surgeon can increase the diameter of the expandable tube 106 by attaching top housing 102 to the expandable tube 106, seating the top housing 102 in the bottom housing 104, attaching the expandable tube 106 to the bottom housing 104, and rotating the top housing 102 relative to the bottom housing 104 causing the expandable tube 106 to a least partially uncoil, creating a larger working channel.
  • the diameter of the expandable tube 106 can be increased to 27, 26, 25, 24, 23, 23, 22, 21, 20, 19, 18 ga. (0.4 - 1 mm), or larger.
  • the diameter of the tube 106 can be expanded from a first position to a second position by between about 1 % and 80 %, or between about 20% and 40%.
  • FIG. 2 shows the adjustable cannula 100 of FIG. 1 in exploded perspective.
  • Bottom housing 104 includes a first lumen 110, through which tube 106 passes and in which locking mechanism 112 is rotatably received.
  • Bottom housing 104 also includes a second smaller lumen (shown below) through which tube 106 is inserted and a slot (also shown below) for coupling with coupling element 114 of tube 106. While the coupling element 114 is in the form of a tab or protrusion, the coupling element is not limited to these particular shapes or forms.
  • the flange or lip 116 helps to retain the tube 106 in bottom housing 104.
  • the coupling element 118 of tube 106 couples with the top housing 102 via slot 120.
  • coupling element 114 while coupling element 118 is in the form of a tab or protrusion, the coupling element is not limited to these particular shapes or forms.
  • a user rotating top housing 102 in a clockwise direction while holding bottom housing 104 stationary or rotating bottom housing in a counter-clockwise direction causes expandable tube 106 to expand.
  • the components can be configured such that the top housing 102 can be rotated in a counter-clockwise direction to cause expandable tube 106 to expand.
  • locking mechanism 112 has a slight taper that mates with a taper of lumen 110 so that top housing 102 is snuggly and rotatably coupled to bottom housing 104.
  • top housing 102 includes a protrusion (shown below) that matingly seats with notches 122, essentially forming a detent mechanism to hold expandable tube 106 at a desired diameter.
  • the coupling of the top and bottom housings 102 and 104 forms a detent mechanism providing and maintaining a plurality of expandable tube 106 diameters when the top housing 102 is rotated relative to the bottom housing 104.
  • Expandable tube 106 is preferably made at least in part of a thin, resilient material such as nitinol (a memory metal) or other shape memory alloy (e.g., Cu-Al-Ni), stainless steel, or other suitable material that can form a sufficiently small diameter coil and yet be robust enough not to collapse against the pressure of stretched tissue.
  • the tube 106 can be composed of a plastic with metal (e.g., nitinol) pieces embedded therein.
  • metal e.g., nitinol
  • having the exposed portion of the cannula formed of plastic advantageously minimizes the risk of harm to surrounding tissue caused during expansion, as plastic is more deformable relative to metal and does not apply the same degree of force in multiple directions as metal.
  • the materials can be biocompatible, or can be provided with a protective layer (e.g., of aluminum oxide) to enhance biocompatibility.
  • the expandable tube 106 can be formed in part of a material that has an elasticity of between 20x10 6 psi and 2x10 6 psi that allows the expandable tube 106 to return to an original, non-expanded state with ease. Such elastic material advantageously allows the expandable tube 106 to be used multiple times in different surgical operations, without having concern about long-term deformation.
  • the coil can cooperate with tissue to assist in sealing the interior of the cannula (e.g., such as when the coil is expanded).
  • tissue e.g., such as when the coil is expanded.
  • the edges of the coil can be slanted toward the interior portion of the coil, thereby allowing tissue to slide off the slanted edges and away from the interior portion of the coil during coil expansion or contraction.
  • the coil can be provided with a biocompatible coating that reduces the friction between coil and the tissue/other materials, thereby reducing the risk of capturing tissue and other materials by the coil.
  • the surface of the coil can be substantially smooth to allow tissue and other materials to slide off the coil, thereby preventing tissue or materials from being captured by the coil.
  • the coil is substantially tightly wound to reduce the amount of the space between layers of the coil, thereby preventing tissue and other materials from becoming captured by the coil.
  • FIG. 3 is a partially exploded perspective of another example of an adjustable cannula 124.
  • Adjustable cannula 124 is essentially the same as the example shown in FIG. 2 , except that bottom housing 126 has more notches 128 for more selectivity regarding the lumen 103 diameter of tube 106. Additionally, bottom housing 126 has several barbs 132 for grabbing tissue to facilitate rotation of top housing 102 with respect to bottom housing 126 and thus, adjustment of the lumen diameter 130 of expandable tube 106.
  • the barbs 132 are formed and integrated with the bottom housing 126, while in other embodiments, the barbs 132 are removably coupled to the bottom housing 126 such that they can be removed if desired.
  • FIG. 4 is a partial exploded perspective of the embodiment of FIG. 2 , showing the coupling of expandable tube 106 to the top and bottom housings 102 and 104.
  • Tab 118 of the expandable tube 106 fits into slot 120 of the top housing 102 as shown by arrow 134.
  • Arrow 136 shows tab 114 of the expandable tube 106 fitting into slot 138 of the bottom housing 104.
  • the bottom housing 104 is coupled to the expandable tube 106 via a first tab 114, while the top housing 102 is coupled to the expandable tube via a second tab 118. Rotation of the top housing 102 relative to the bottom housing 104 results in expansion or contraction of the expandable tube 106.
  • the view in FIG. 4 also shows the second smaller lumen 140 of bottom housing 104.
  • the second lumen 140 receives the expandable tube 106.
  • the second lumen 140 may be configured to limit a maximum diameter size to which the tube 106 can be expanded.
  • second lumen 140 is a safety mechanism preventing the expandable tube 106 from expanding too much and damaging or tearing the surrounding tissue.
  • the second lumen 140 can be sized to limit the tube 106 from expanding beyond accommodating a 20 ga. instrument and protect the sclera from tearing or other damage.
  • the second lumen 140 can be configured to limit the tube 106 from expanding beyond a maximum design limit (example 4mm) to prevent surrounding tissue from tearing, or becoming damaged.
  • the expandable tube 106 shown in partial perspective in FIG. 5 , is a coiled or a wound-up material.
  • the expandable tube 106 can be constructed of metal (for example, nitinol), a plastic, or a polymer, or combination thereof.
  • the thickness of the tube 106 material can be about 0.001 inches (0.0254 mm), and can range from about 0.001 inches (0.0254 mm) to about 0.01 inches (0.254 mm).
  • the expandable tube 106 can have a length of between 3 mm and 15 mm.
  • the expandable tube 106 comprises a distal end (shown in above figures) for insertion into the eye, and a proximal end 142 which preferably remains external to the eye during use. Flange 116 prevents tube 106 from passing through lumen 140, shown in FIG. 4 .
  • FIG. 6 is a perspective view of top housing 102 showing attachment mechanism 112, slot 120, and lumen 144.
  • Lumen 144 receives instruments and materials to be inserted into or removed from the eye and communicates with lumen 140 of tube 106. Instruments can include, for example, biopsy devices, scissors, tissue cutting and/or removal devices, draining devices, endoilluminators, fluid infusion devices, and the other surgical instruments.
  • a groove 146 spans the diameter of top housing 102. In some embodiments, an instrument having a mating end can be inserted into the groove 146 and can assist in clockwise or counter-clockwise rotation of the top housing 102.
  • FIG. 7 is a perspective of bottom housing 104 clearly showing first lumen 110, second lumen 140, notches 122 and slot 138 for coupling with tab 114. From this angle, the notches 122 are shown as grooves along the perimeter of the cannula. Also from this angle, it is shown that in some embodiments the slot 138 can be curved or angled. This design of the slot 138 advantageously helps to secure a tab member 114 within the bottom housing 104.
  • an adjustable cannula in accordance with the present invention, the user can rotate the top housing 102, which engages tab 118 causing the expandable tube 106 to also rotate with respect to bottom housing 104.
  • the expandable tube 106 either coils or uncoils causing the lumen 140 diameter of the expandable tube 106 to decrease or increase.
  • the coiling or uncoiling can occur because the tab 118 is held fixed or substantially fixed or in position through engagement with the bottom housing 104.
  • bottom housing 104 may be anchored to tissue or held by the physician to allow the relative rotation of top housing 102.
  • the expandable tube 106 With the tab 118 rotating while the tab 114 is fixed or substantially fixed, the expandable tube 106 is increased or decreased in diameter, thereby increasing or decreasing the diameter of the working channel, i.e. lumen 140.
  • the expandable tube 106 is configured to uniformly expand and contract or substantially uniformly expand and contract at the proximal end and the distal end, as the user rotates the top housing 102.
  • the expansion and contraction of proximal end 142 may be greater than the expansion and contraction of the distal end of tube 106.
  • the expandable tube 106 may be extracted after reducing the expandable tube 106 to a smaller diameter, preferably as small as possible to minimize trauma to surrounding tissue during extraction.
  • the locking mechanism 112 can engage the lower housing element 104 to lock the top housing 102 in a user selected position and maintain a particular diameter of the expandable tube 106.
  • the locking mechanism 112 can comprise flexible fingers 148 extending distally and with spacing 150 between each finger 148.
  • the distal ends of the fingers 148 are configured to taper or push outward so as to exert a radial outward force against the inner surface of bottom housing 104 defining lumen 110 to engage the top housing 102 with the bottom housing 104 and retain the top housing 102 connected with the bottom housing element 104.
  • lumen 110 is partially conical or tapers.
  • the lumen 110 has a wider distal end (larger diameter) and a narrower proximal end (smaller diameter).
  • the fingers 148 form a partially conical shape, i.e. the fingers 148 form a wider distal region (larger diameter) and narrower proximal region (smaller diameter).
  • the user may pull the top housing 102 proximally outward or away from the bottom housing 104 causing the flexible fingers 148 to be pushed inward as the flexible fingers 148 are forced into the narrower portions of the lumen 110.
  • the resilient force of the flexible fingers 148 pushes the fingers 148 distally inward into the lumen 110, allowing the flanges to return to a more relaxed state.
  • FIG. 8 discloses another example of an adjustable cannula 200 where cannula 200 is an elongate body with a proximal end 202, a distal end 204, and a middle region 206 between the proximal and distal ends. As can be seen, there is no particular structure delineating the proximal end 202 from the middle region 206 or the middle region 206 from the distal end 204.
  • the terms proximal end, middle region, and distal end are intended to refer to the general areas of the cannula 200 and not to a specific spot or place on cannula 200.
  • the initial diameter of the adjustable cannula 200 at the proximal end 202 can be larger than the initial diameter of the cannula 200 at the distal end 204 and the middle region 206.
  • the distal end 204 and the middle region 206 are formed by elongated flanges 208 configured to flex when an object, fluid, gas, tissue, device, or the like is inserted through the lumen 210. As the flanges 208 flex, the working channel or diameter of cannula 200 increases and decreases. Sufficient force of the flanges 208 pressing against the resilient elastic surrounding tissue allows the increase of the working channel.
  • an instrument e.g., such as a probe
  • the flanges 208 of the cannula 200 are separated by slits 212.
  • the slits 212 of the cannula 200 can cooperate with surrounding tissue to assist in sealing or maintaining closure of the interior of the cannula 200.
  • the slits 212 of the cannula Upon expansion of the cannula walls, the slits 212 of the cannula also expand, such that the openings of the slits 212 can increase.
  • the slits 212 of the cannula 200 can advantageously cooperate with the surrounding tissue to thereby maintain closure of the interior lumen of the cannula.
  • the tissue which is generally elastic, can advantageously occupy all or a portion of the spaces in the openings of the slits, thereby providing a blocking function by serving as the "walls" of the cannula. Accordingly, liquid in the cannula can be inhibited from leaking out due to the blocking tissue, even when the cannula 200 is expanded.
  • the cannula 200 comprises two or more slits 212, such as three, four, five, six, seven or eight slits.
  • the cannula 200 comprises a single slit such that the cannula is "C-shaped."
  • the number of slits 212 can affect the performance of the cannula in transporting fluids and tissue. For example, a fewer number of slits can result in the slit openings or the gap size of the slits being larger in size during cannula expansion, which can result in tissue being inadvertently captured in the slit openings during contraction following expansion such that the slits remain open.
  • an expanded cannula with fewer slits can increase the gap size of the slits may increase, thereby increasing the chances of capturing or catching tissue or other unwanted material in the slits while the cannula is contracting. While increasing the number of slits may reduce the gap size of the slits, and thus the risk of capturing or catching material in the slits during contraction, the strength or rigidity of the cannula walls may decrease, which is important for preventing collapse of the cannula during insertion. Accordingly, a cannula for insertion may benefit from at least two or three slits and fewer than five or six slits.
  • the number of slit can range from 2-10, or 1-20, or 1-25.
  • One skilled in the art will realize however that providing a cannula with at least one slit can provide numerous advantages over conventional cannulas without slits.
  • the one or more slits 212 advantageously accommodate and modulate expansion and contraction of the cannula. While the expansion and contraction can occur by an electrical, mechanical or magnetic means, in some embodiments, the expansion and contraction are performed mechanically means, by insert of, for example, a probe (as shown in FIG. 15C ).
  • the slits can be positioned symmetrically around the cannula (e.g., three slits at a 120 degrees apart) or asymmetrically. In some embodiments, two or more slits can have similar widths, while in other embodiments, two or more slits can be of varying widths.
  • having slits advantageously allow tissue (e.g., scar tissue as in diabetic retinopathy) or other material (e.g., a foreign body such as a piece of metal during hammering) to be removed from the eye, that has entered the eye.
  • tissue e.g., scar tissue as in diabetic retinopathy
  • other material e.g., a foreign body such as a piece of metal during hammering
  • the walls of the slits 212 can be configured to allow tissue or other materials to squeezed out or otherwise removed while the walls of the cannula contract from an expanded state.
  • the side walls of the slits 212 can be substantially smooth so as to reduce the risk of catching or capturing tissue or other materials during contraction.
  • the side walls of a slit 212 can form a substantially wedge shaped configuration to prevent tissue or other materials from being captured in the slits during contraction. The open side of the wedge can face into the interior of the cannula or face outwardly to the exterior of the cannula.
  • the side walls of a slit 212 can be substantially curved or rounded to prevent tissue or other materials from being captured in the slits during contraction.
  • the side walls of the slit 212 can also comprise a coating, for example, Teflon, to prevent tissue or other materials from being captured in the slits during contraction.
  • An additional advantage of having a cannula 200 with slits 212 is that viscous fluids, which would otherwise be very difficult to push through a small cannula, can be more easily pushed through one with the slits 212, as the slits 212 can open up under pressure of the fluid. For example, infusing 1000 centisoke or 5000 centisoke silicone oil in the eye can result in an opening of the slits when desired. Adding such fluids removes the need to use an instrument or probe to open the slits 212.
  • a mechanical means can be provided to force the expansion.
  • the mechanical means comprises a probe (as shown in FIG. 15C ) that can be inserted into the cannula 200 to expand the flanges 208.
  • the probe can comprise a light source, cutter, diathermy tool, or any other surgical instrument capable of insertion into the cannula 200 and forcing expansion of the cannula 200.
  • Other probes can also include but are not limited to scissors, blades, picks, forceps, and lens removal devices for dropped lens fragments.
  • the interior walls of the cannula 200 will expand outward.
  • the proximal most end of the cannula 200 (which may not include a slit) need not be expandable, and can be set to the maximum probe size available for the procedure.
  • the slits 212 help to mechanically accommodate and modulate the degree of expansion of the cannula 200.
  • the cannula 200 Upon removal of the probe, the cannula 200 will contract to a reduced size.
  • the adjustable cannula 200 with slits 212 is user friendly because it requires no forceful mechanical manipulation of the cannula 200 to expand or contract the diameter of the cannula.
  • the adjustable cannula 200 with slits 212 requires no moving parts and thus can be easily manufactured with a single injection molding process.
  • one or more probes can be of a single size, such that expansion of the cannula 200 is achieved by using multiple probes that increase in size.
  • three different probes of various increasing gauges e.g., 25 ga., 23 ga. and 20 ga.
  • a probe can be of an adjustable size, such that only a single probe need be used to assist in the expansion of the cannula 200.
  • the probe can have a hollow interior to allow for tools or instruments, as well as liquids and tissue, to pass therethrough.
  • the probe can therefore serve as both an expansion tool for the cannula 200 with slits 212, as well as access port to access a target site.
  • flanges 208 are prevented from separating at their extreme distal ends by material 214.
  • material 214 may be formed of the same material as flanges 208 and molded simultaneously with cannula 200 in manufacture, such that the elongate body is a single unitary molded piece.
  • material 214 is optional, and that in other embodiments, the cannula may be expandable even at its extreme distal end.
  • material 214 may be a ring of material placed or attached to flanges 208, as shown in detail below.
  • Material 214 may serve one or more purposes. These purposes include maintaining a small initial diameter of the distal end 204 and middle region 206 as cannula is inserted into tissue by a trocar (not shown) held within cannula 200 and extending beyond distal end 204.
  • Another purpose of material 214 is to allow the flanges to flex and slits 212 to expand under the pressure of viscoelastic being inserted into the eye, thereby effectively enlarging the volume of the cannula 200 in the eye to allow faster and easier injection of viscoelastic.
  • the flanges 208 may return to an unflexed state with minimal width slits 212 to assist in preventing fluid escaping the eye.
  • An alternate purpose of material 214 is to be only robust enough to maintain the initial small diameter during insertion of cannula 200 into tissue but weak enough to break upon the insertion of a device larger in diameter than the initial small diameter. In this way, flanges 208 are allowed to separate from each other and flex or bend outwardly to provide a wider working channel.
  • Lumen 210 may be large enough to accommodate and define the largest acceptable diameter that flanges 208 are allowed to flex, such as for a 20 ga. or greater vitreous cutter, while the distal end and middle region diameters are small enough to require a minimal sized incision in the tissue, similar to that describe above with respect to expandable tube 106.
  • slits 212 can extend a substantial length, even a majority of the length, of cannula 200 and at least long enough to allow flanges 208 to separate sufficiently to accommodate the largest diameter device compatible with lumen 210.
  • the slits 212 can extend from a distal end 204 to a wider proximal end 202 of the cannula 200.
  • a series of multiple slits can extend along a single line and can be provided to accommodate expansion and contraction of the slits.
  • a proximal end 202 of the cannula 200 in a non-expanded state, can have a larger diameter than a middle 206 and/or distal end 204 of the cannula.
  • the proximal end 202 of the cannula 200 remains outside of patient (e.g., outside of an eye) such that it need not be expanded or contracted. Rather, it can be sized larger than the middle 206 and/or distal end 204 of the cannula 200 to thereby facilitate the insertion of instruments into the cannula, and provide greater visual access to a surgeon utilizing the cannula.
  • the broader proximal portion of the instrument can be inserted with ease into the broader proximal end 2020 of the cannula 200.
  • the middle 206 and/or distal end 204 can be less than, the same as, or greater than the diameter of the proximal end 202 of the cannula 200.
  • the cannula 200 can be comprised in part or substantially of a plastic material.
  • the plastic can be injection molded, such as in a single shot.
  • Different plastic-based materials can be used to form the cannula 200, including but not limited to organic and synthetic polymers, polyamide (Nylon), polyoxymethylene (Delrin), parylene, and polyurethane.
  • the cannula 200 can be formed of a plastic-based material that provides sufficient rigidity to the cannula 200, while also maintaining some degree of flexible to accommodate expansion and contraction of the cannula 200 during use.
  • the cannula 200 can have a Flexural Modulus of between 3x10 5 PSI and 5x10 5 PSI.
  • the cannula 200 can be formed of a plastic with metal pieces embedded therein.
  • FIG. 9 is a perspective of another example of an adjustable cannula 216 in accordance with the present invention.
  • Cannula 216 is essentially the same as cannula 200 except that material 214 is replaced by ring 218.
  • the ring 218 is removable.
  • Ring 218 may be resilient and expandable or rigid, depending on the purpose of using cannula 216. Ring 218 may be adhered to cannula 216 with an acceptable adhesive or may be held in place by any known attachment mechanism.
  • the cannulas 200 and 216 may be used alone with a trocar device, or with top and bottom housings 102 and 104, as shown in FIGS. 10A and 10B .
  • the top and/or bottom housings 102 and 104 may be used to provide more structure to hold cannulas 200 or 216 in place during surgery. Though slots 120 and 138 are shown, they are not needed for cannulas 200 and 216.
  • Flange or rim 220 is held between bottom housing 104 and the fingers (not shown) of top housing 102.
  • the top housing 102 comprises at least one ridge element 107 configured to engage a plurality of grooves or notches 122 and 124 in the bottom housing 104.
  • the first and second notches 122 and 124 are sized and configured to securely position at least one ridge element 107.
  • the at least one ridge element 107 is configured to fit within notch 122 to lock the top housing 102 into a particular position.
  • the user can pull the top housing 102 proximally outward and rotate the top housing 102 to disengage the ridge element 107 from the notch 122 and engage a second notch 124.
  • the cannula 200 can expand or contract. Accordingly, the cannula can be securely kept in a first state while the ridge element 107 is in a first notch 122, and securely kept in a second expanded or contracted state relative to the first state while the ridge element 107 is in a second notch 124.
  • FIG. 11 shows another cannula 222 and differs from cannula 200 in that flanges 224 taper so that slits 226 between flanges 224 progressively widen towards the distal end of cannula 222, thereby advantageously providing for varied expansion along the length of the cannula.
  • this configuration of flanges 224 may be advantageous such as providing more space for maneuvering instruments during surgery.
  • FIG. 12 shows yet another cannula 228 having flanges 230 with thermodynamically changing material 232 filling the space between the flanges 230.
  • Material 230 has an initial small cross-sectional width upon insertion into tissue and expands to a subsequent larger cross-sectional width at some time after insertion into tissue so that the working channel of cannula 228 is enlarged by the force of material 230 expanding causing flanges 230 to further separate.
  • Material 230 can be attached between flanges 230 by any known manufacturing techniques including adhesive, molding, injection, etc. Material 230, depending on the amount of expansion and contraction needed, can be any number of materials such as various hydrogels.
  • Material 230 may begin at a low temperature by being quickly treated with a Cryo-device, often used in many surgeries, immediately before insertion and then material 230 may increase in temperature from contact with surrounding tissue and materials being injected and aspirated from the surgical site. As material 230 increases in temperature, material 230 expands. Material 230 may also take the form of hydrophilic materials. Hydrophilic materials absorb moisture and expand as moisture is absorbed and therefore material 230 causes flanges 230 to separate from each other, expanding the working channel of cannula 228.
  • FIG. 13 is yet another example of a cannula 234 having a housing 236 with several flanges 238 attached.
  • housing 236 is a single molded device having a tapering entry lumen 240 with flanges 238 attached by any acceptable method such as adhesive.
  • the entry lumen defines the maximum working channel allowed by cannula 234 and flanges are attached such that they are able to expand and deflect beginning immediately at the interface with housing 236 at lumen 240.
  • the cannula 234 may be formed by insert molding a tube (e.g., nitinol) composed of flanges 238 (e.g. super elastic nitinol) into polymer housing 236.
  • a tube e.g., nitinol
  • flanges 238 e.g. super elastic nitinol
  • Cannula 234 has several specific features, including several slits (five in this example) distributed substantially symmetrically about the cannula body, a wider proximal end than distal end, and the wider proximal end of flanges 238 is within housing 236 that is placed on the tissue outside the surgical site.
  • an expandable member 306 similar to the expandable member 106 is coupled to an electrical energy source 330.
  • the electrical energy source 330 can be configured to apply a current to the expandable member 306, which can be controlled by a switch 319.
  • the expandable member 306 can be configured to increase or decrease in diameter.
  • the amount of electrical current applied to the expandable member ranges between I nanoamp and 100 microamps.
  • the electrical current does not damage or injure the eye or the surrounding tissue, as the current may be insulated from the tissue (e.g., by an insulating layer).
  • a grounding path may be used to protect the patient and surrounding tissue from harm.
  • a ground 327 is operatively connected to the eye 101 to assist in the grounding process.
  • a proximal end of the expandable member 306 is coupled to the electrical energy source 330.
  • the expandable member 306 can be part of a cannula system that can be anchored in the pars plana of an eyeball.
  • the expandable member 306 can increase or decrease from one gauge to another when electrical energy is applied by the electrical energy source 330.
  • the expandable member 306 can be extracted by reducing a diameter of the expandable member to a larger gauge by varying the electrical energy applied by the electrical energy source 330.
  • FIG. 15A is a perspective of yet another example of a cannula with upper housing in accordance with the present invention.
  • the cannula includes an expandable member 400 including a proximal portion 402 and a distal portion 404.
  • the proximal portion 402 In an unexpanded state, the proximal portion 402 has a larger cross-sectional area than the distal portion 404 to form a generally conical shape or cone-like configuration.
  • the expandable member 400 comprises a foldable or winding coil that has an ending edge 415, as shown in FIG. 15A .
  • the ending edge 415 is positioned on the surface of the expandable member 400 diagonally relative to a longitudinal axis extending between the distal end and proximal end of the expandable member 400 because the diameter of the proximal end is larger than the diameter of the distal end of the expandable member 400.
  • the ending edge 415 can comprise a substantially smooth edge, a curved edge, a slanted edge, a coating, or other edge configuration to prevent tissue from being captured by the ending edge 415 as the expandable member 400 expands and contracts.
  • an upper housing 482 which can couple with the expandable member 400.
  • the expandable member 400 and upper housing 482 form an adjustable cannula system that can expand and contract via a mechanical force (e.g., a probe) as discussed with respect to FIG. 15C .
  • FIG. 15B illustrates the cannula of FIG. 15A being coupled or being inserted into an upper housing.
  • the expandable member 400 of the cannula can be coupled to the upper housing 482 by any of the methods described above or can merely placed into the housing be snapped into place or be held in place due to frictional forces.
  • the expandable member 400 can include a tab capable of mating with a mateable portion (e.g., a slot) in the upper housing 482.
  • the expandable member 400 of the cannula and the upper housing 482 are formed as a single piece.
  • FIG. 15C illustrates the cannula of FIG. 15B being expanded via use of a probe.
  • the cannula having expandable member 400 in the form of a winding coil can also be expanded using a probe 450.
  • the probe 450 is hollow, such that instruments, tools or tissue can be introduced through the probe.
  • the probe is an instrument or device that can include, for example, biopsy devices, scissors, tissue cutting and/or removal devices, draining devices, light sources, fluid infusion devices, and the other surgical instruments. While introducing the probe 450 into the expandable member 400 can result in expansion, removing the probe 450 from the expandable member 400 can result in contraction.
  • the cannula described in FIGS. 15A-15C allows for introduction into tissue a cannula of narrow size that can controllably expand only if desired to larger sizes, thereby reducing the risk of injury of tissue and the need for sutures. Further, the cannula illustrated in FIGS. 15A-15C does not require twisting of the housing portion to expand or contract the diameter of the cannula, rather expansion and contraction occurs when a probe is inserted or removed from the cannula.
  • the cannula 400 is of a material that is sufficiently elastic to allow for expansion of one or more coils, and sufficiently stiff to prevent collapse of the cannula during the expansion.
  • Such material can include various plastics and metals (including metal alloys), as well as plastics with metal embedded therein.
  • the geometry of the cannula 400 can also be controlled to minimize the damage to the surrounding tissue performed by the cannula 400 when it is introduced and/or expanded within an eye. Controlling the geometry can provide for sufficient stiffness, while providing sufficient flexibility to the cannula to allow for expansion.
  • FIG. 16A is a perspective of yet another example of a cannula with housing in accordance with the present invention.
  • the cannula includes an expandable member 500 including a proximal portion 502 and a distal portion 504, wherein the proximal portion 502 has a larger cross-sectional area than the distal portion 504 in an unexpanded state.
  • the expandable member 500 Along the body of the expandable member 500 are a plurality of flutes or folds 516.
  • the folds 516 extend along a majority of the length of the expandable member 500, from the proximal portion 502 to a furthest most distal end 520 of the distal portion 504, although the folds need not assume such a length in every embodiment (for example, the proximal portion need not be fluted). Due to the folds 516, the distal end 520 includes a number of edge points as shown in FIG. 16A . Also shown is a housing 582 which is coupled with the expandable member 500. The expandable member 500 and housing 582 form an adjustable cannula system that can expand and contract via a mechanical force (e.g., a probe) as discussed with respect to FIG. 15C . In some embodiments, the cannula can be formed at least in part of a metal, metal alloy (e.g., nitinol) or polymer, or any combination thereof.
  • a metal, metal alloy e.g., nitinol
  • polymer e.g., polymer, or
  • FIG. 16B illustrates the cannula of FIG. 16A in an expanded form that has been expanded via use of a probe.
  • the folds 516 of the expandable member 500 accommodate expansion.
  • the folds of the expandable member 500 can expand outward, such that the expandable member 500 is left with a substantially smooth surface.
  • the expandable member 500 can assume a cylindrical shape such that the distal end 520 appears circular.
  • the cannula described in FIGS. 16A and 16B allows for introduction into tissue a cannula of narrow size that can controllably expand only if desired to larger sizes, thereby reducing the risk of injury of tissue and the need for sutures.
  • FIG. 17A is a perspective of yet another example of a cannula with housing in accordance with the present invention.
  • the cannula includes an expandable member 600 including a proximal portion 602 and a distal portion 604, wherein the proximal portion 602 has a larger cross-sectional area than the distal portion 604 in an unexpanded state.
  • the expandable member 600 are a plurality of actuating elements 616 that can expand into a cross-hatched or cage pattern (as shown in FIG. 17B ).
  • the actuating elements 616 extend along a majority of the length of the expandable member 600, from the proximal portion 602 to the distal portion 604, although in other embodiments, the actuating elements 616 can extend a lesser portion along the length of the expandable member 600 (e.g., the proximal portion need not have the actuating elements).
  • a housing 682 which is coupled with the expandable member 600.
  • the expandable member 600 and housing 682 form an adjustable cannula system that can expand and contract via a mechanical force (e.g., a probe) as discussed with respect to FIG. 15C .
  • the cannula can be formed at least in part of a metal, metal alloy (e.g., nitinol) or polymer, or any combination thereof.
  • FIG. 17B illustrates a distal portion of the cannula of FIG. 17A in an expanded form via use of a probe.
  • the actuating elements 616 of the expandable member 600 accommodate expansion.
  • the actuating elements 616 can expand outward and form a cross-hatched or cage pattern.
  • the cannula in an expanded form can resemble a wire-frame.
  • the exposed cross-hatched areas can interact with tissue to provide a seal for the cannula, while in other embodiments, the exposed cross-hatched areas can be surrounded by a thin film or membrane that can be contractible with the cannula to prevent liquids and other materials form inadvertently entering and/or escaping the lumen of the cannula.
  • the cannula described in FIGS. 17A and 17B allows for introduction into tissue a cannula of narrow size that can controllably expand only if desired to larger sizes, thereby reducing the risk of injury of tissue and the need for sutures.
  • adjustable cannulas that allow a small initial incision to be made but yet allow use of larger port sizes during surgery while allowing the incision to return to a size that may be self-sealing and without the need for sutures.
  • the following are some comments regarding some possible variations of the examples described above. These statements and variations are not to be considered exhaustive or the only variations possible in accordance with the present invention, but only for further illustrative purposes.
  • the adjustable cannula 200 can be tapered such that it is of a reduced diameter in a distal portion relative to a proximal portion.
  • the cannula 200 is configured to be naturally tapered upon entering a body cavity, while in other embodiments, the cannula 200 is configured to be naturally non-tapered but will taper in whole or in part upon expansion of the cannula.
  • the walls of the cannula 200 are tapered. The advantage of having a tapered cannula or tapered walls is that surrounding tissue is less likely to be disturbed around the narrowest sections of the tapered cannula 200, and certain tissue will only be affected if the cannula 200 is expanded.
  • the cannula 200 comprises an adjustable seal located at a distal portion or proximal portion of the cannula, as is known, to prevent the escape of liquids and gases within the cannula, as well as the influx of unwanted materials into the cannula 200.
  • the seal can comprise a film or diaphragm that adjusts with the cannula during expansion and contraction.
  • the seal can comprise a shutter ring or valve that adjusts into various positions (e.g., fully opened, partially opened, fully closed) in accordance with the state of the cannula.
  • the adjustable seal can also interact with surrounding tissue such that when there is an opening in the seal, the surrounding tissue can help provide a blocking function.

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WO2011037941A1 (fr) 2011-03-31
US20120172668A1 (en) 2012-07-05
EP2480280B1 (fr) 2017-02-01
US20190000507A1 (en) 2019-01-03
EP2480280A4 (fr) 2013-05-01
ES2623399T3 (es) 2017-07-11
EP2480280A1 (fr) 2012-08-01
US20160066951A1 (en) 2016-03-10
US10076359B2 (en) 2018-09-18
US9198797B2 (en) 2015-12-01

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